NDC Code(s) : 49999-766-20, 49999-766-28
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AmoxicillinAmoxicillin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49999-766(NDC:0781-5061)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amoxicillin(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS875 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSES(UNII: 3NXW29V3WO)
magnesium stearate(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
talc(UNII: 7SEV7J4R1U)
triethyl citrate(UNII: 8Z96QXD6UM)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color white (slightly yellowish) Score 2 pieces
Shape OVAL Size 21 mm
Flavor Imprint Code GG;962;875
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49999-766-2020 in 1 BOTTLE Type 0: Not a Combination Product15/12/2011
2NDC:49999-766-2828 in 1 BOTTLE Type 0: Not a Combination Product15/12/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065228 12/15/2011 06/01/2014

PRINCIPAL DISPLAY PANEL

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